Freenome Receives FDA Breakthrough Device Designation for SimpleScreen Lung Cancer Test

Freenome says its SimpleScreen™ lung cancer screening test received FDA breakthrough device designation, a regulatory status intended to accelerate the development and review of promising medical technologies. The company highlighted the test’s blood‑based approach as a less invasive alternative to current imaging methods.

FDA officials noted that the SimpleScreen test could enable earlier detection of lung cancer by analyzing circulating tumor DNA in a standard blood sample, potentially reducing the need for low‑dose CT scans in high‑risk populations and lowering overall screening costs.

SimpleScreen is slated to enter pivotal clinical trials later this year, with plans to enroll thousands of smokers and former smokers across multiple U.S. sites, aiming to validate its sensitivity and specificity compared with existing imaging standards.

Designation provides Freenome with priority review pathways and eligibility for FDA’s Breakthrough Devices Program resources, which could shorten time to market and expand access to early lung cancer detection for patients nationwide.